Expert Details
Clinical Development, Regulatory Development
ID: 730696
Italy
He offers consultancy services relating to project management for preclinical and early clinical development programmes, design, costing, time lines, risk analysis, review of study protocols, CSRs, ICFs, DMPs, SAPs, DVPs etc as well as selection and qualification of service providers. He also provides advice regarding regulatory strategy for preclinical and early (Phase I-IIb) clinical programmes, preparation, review and submission of CTA/IMPDs, INDs (eCTD format) and Annual Reports, Investigator Brochures, Orphan Designation Dossiers, EMA SAWP Scientific Advice/Protocol Assistance Dossiers and can also provide consultancy regarding identification, qualification and selection of service providers for API/CMC, toxicology, bioanalytical chemistry.
In 2011, Expert was named one of the Experts on the European Commission panel and is also an expert in the clinical development area. Expert is also on the EUREKA panel as an evaluator.
He has extensive experience of Due Diligence/in-licensing evaluations as regards regulated preclinical and clinical pharmacology aspects, and can provide structured summaries of risks and required actions as a support to licensing decisions. Expert is a pharmacokineticist and provides pharmacokinetic and advanced PK/PD support (WinNonLin platform) as well as statistical analysis in suppport of study design, power calculations etc. Specialty areas include radioactivity-based imaging (whole-body autoradiography, positron emission tomography) (PET)), support to European Commission Framework Programme applications. He is the author of more than 80 publications in peer-reviewed scientific journals and has often served as a referee both for journals and for public and private research-funding bodies.
Designed and conducted entire preclinical and Phase I-II package for an NCE for a small pharma client, with full responsibility for management of external vendors. Compiled all relevant regulatory documentation and submissions. Programme currently in Phase IIb and ready for licensing.PK/PD modelling of clinical data in support of pivotal efficacy programme in infectious disease. Design and implementation of clinical pharmacology studies to support later phase efficacy studies. Regulatory consultancy and design of subsequent clinical development plan. Compilation of EMA SAWP Scientific Advice/Protocol Assistance Dossier.Costing and service provider selection for neurological product; PK/PD modelling in support of human dose selection. Conducted FTIH study on behalf of client, including compilation and submission of study protool, IB, IMPD, CTA, as well as PIL/ICF; management of all regulatory/Ethics and Clinical operations. Review and approval of CSR.Due Diligence reviews of multiple (>40) commercial opportunities on behalf of a medium EU Pharma organization.Compilation of complete eCTD for US/FDA filing of NDA for a dermatological product based on (>100) individual study reports.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1997 | Degree: Associate Professor | Subject: Radiopharmacy | Institution: University of Uppsala |
| Year: 1994 | Degree: PhD | Subject: Radiopharmacy | Institution: University of Uppsala |
| Year: 1991 | Degree: MSc | Subject: Radiopharmacy | Institution: University of Uppsala |
| Year: 1988 | Degree: BSc | Subject: Organic Chemistry | Institution: University of Uppsala |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2012 to Present | Employer: Undisclosed | Title: Owner & Director | Department: |
Responsibilities:Offers consultancy and advisory services to the Life Sciences Sector, particularly regarding the early Clinical Development phases and Regulatory Affairs. Provides a helicopter view of all facets of the development process from Preclinical Candidate to the start of registrational studies, including setting up development plans, selection, qualification and management of service providers, clinical study design, construction of budgets, risk management and decision trees. Regulatory services include compilation of CTA/IMPDs, INDs, IBs, Scientific Advice/Protocol Assistance dossiers, Orphan Designation dossiers and support in responding to regulatory questions and requests. Additional services include support to the In- or Outlicensing process as well as compilation of Business Plans. |
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| Years | Employer | Title | Department |
| Years: 2004 to 2012 | Employer: Siena Biotech SpA | Title: Director | Department: Clinical & Regulatory Development |
Responsibilities:Director of Clinical & Regulatory Development; from 2004-2011 also with responsibility for Preclinical Development (Toxicology, Pharmaceutical Development, ADME/PK). |
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| Years | Employer | Title | Department |
| Years: 2000 to 2004 | Employer: Pfizer | Title: Director | Department: Clinical Pharmacokinetics |
Responsibilities:Responsibility for pharmacokinetic and modelling support across global project portfolio, with emphasis on oncology, urology and CNS. |
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| Years | Employer | Title | Department |
| Years: 1997 to 2000 | Employer: Pharmacia & Upjohn | Title: Research Advisor | Department: Global Drug Metabolism |
Responsibilities:Responsibility for integrate support across project portfolio with emphais on linking Discovery Research to early Clinical Development. Metabolic diseases and cardiovascular. |
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| Years | Employer | Title | Department |
| Years: 1988 to 1997 | Employer: Uppsala PET Centre | Title: Senior Scientist | Department: |
Responsibilities:Contract Research relating to PET imaging, primarily with Big Pharma clients; proof-of-principle studies, receptor occupancy, drug distribution (inhaled, intranasal), PK/PD. |
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Government Experience
| Years | Agency | Role | Description |
|---|---|---|---|
| Years: 2011 to 2012 | Agency: European Commission | Role: Expert evaluator | Description: Evaluation of proposals under the 7th Framework Programme and the Horizon 2020 Programme |
| Years: 2011 to 2012 | Agency: EUREKA | Role: Expert evaluator | Description: Evaluation of proposals under the Eurostars Programme |
International Experience
| Years | Country / Region | Summary |
|---|---|---|
| Years: 2000 to Present | Country / Region: Italy | Summary: Relocated permanently from Sweden to Italy to take up a position with Pharmacia Inc, Milan. From 2004, Expert is resident in Siena, Tuscany. |
| Years: 1997 to 2004 | Country / Region: United States | Summary: Spent a total of approximately 18 months in the US during the period from 1997 to 2004 as a result of work assignments and secondments with Pharmacia Inc, including Pharmacia sites in San Francisco, Kalamazoo, Skokie, St Louis. |
| Years: 1989 to 1994 | Country / Region: Japan | Summary: Spent a total of approximately 12 months in Japan on secondment during a Joint Venture with the Japan Science and Technology Corporation under the "Subfemtomole Biorecognition Project" on site in Osaka and Hamamatsu. |
| Years: 1988 to 1997 | Country / Region: United Kingdom | Summary: A total of 24 months in the United Kingdom during the 1988-1997 period under contract with a major Pharma organisation. |
Career Accomplishments
| Associations / Societies |
|---|
| Royal Society of Chemistry, Sweden Royal Academy of Pharmaceutical Sciences, Sweden European Federeation of Pharmaceutical Sciences Italian Pharmacological Society |
| Licenses / Certifications |
|---|
| European Association of Nuclear Medicine Certificate |
| Professional Appointments |
|---|
| European Commission Framework Programme Expert; EUREKA Expert Panel |
| Awards / Recognition |
|---|
| The Upjohn Impact Award, (Undisclosed) |
| Publications and Patents Summary |
|---|
| Over 100 publications in peer-reviewed scientific journals; several book chapters and numerous oral presentations at international scientific meetings. Co-inventor on granted patents across the drug discovery/development and devices spectrum. |
Additional Experience
| Training / Seminars |
|---|
| Numerous appearances as invited speaker as business meetings relating to preclinical and clinical outsourcing, modelling, Orphan diseases, Phase I Clinical Trials, Biomarkers |
| Vendor Selection |
|---|
| Extensive experience in vendor selection and qualification across EU/US; invited speaker at outsourcing business meeting. |
| Marketing Experience |
|---|
| Invited expert in GEN Reviews. |
| Other Relevant Experience |
|---|
| Named Expert to the European Commission and EUREKA. |
Language Skills
| Language | Proficiency |
|---|---|
| English | Mother tongue level |
| Swedish | Mother tongue level |
| Italian | Fluent written, read and spoken; capacity to manage budget/finance-, staff- and legal matters in an all-italian organisation. |
Fields of Expertise
clinical pharmacology, clinical protocol, clinical research, clinical research management, clinical study, clinical trial, clinical trial design, clinical trial documents generation, drug clinical trial, drug development, drug interaction, drug metabolite, drug regulation, modeling, pharmaceutical industry, pharmacodynamics, pharmacokinetic modeling, pharmacokinetics, protocol development, radiopharmaceutical drug, regulatory affairs, adverse drug reaction, active pharmaceutical ingredient, Good Clinical Practice, animal study, prodrug, animal drug testing, transdermal drug delivery pharmacokinetics, metabolism, drug bioavailability, bioequivalence, animal model